Cleared Traditional

K063847 - FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR

K063847 is the FDA 510(k) clearance for FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR by Fujinon, Inc.. It is a Class 2 Radiology device (product code FDS) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K063847 · Fujinon, Inc. · Radiology device
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Mar 2007
Decision
64d
Days
Class 2
Risk

K063847 is an FDA 510(k) clearance for the FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Fujinon, Inc. (Shelton, US). The FDA issued a Cleared decision on March 1, 2007 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.1500 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fujinon, Inc. devices

Submission Details

510(k) Number K063847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2006
Decision Date March 01, 2007
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - FDS Gastroscope And Accessories, Flexible/rigid

All 62
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K063847.
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K120446 · Fujinon, Inc. · Aug 2012
FUJINON ULTRASONIC PROCESSOR
K111243 · Fujinon, Inc. · May 2011
FUJINON MODEL EG-530N TRANS NASAL INSERTION
K063316 · Fujinon, Inc. · Mar 2007
KARL STORZ VIDEO GASTROSCOPES
K060907 · KARL STORZ Endoscopy-America, Inc. · Nov 2006
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
K042043 · Fujinon, Inc. · Nov 2004
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · Pentax Precision Instrument Corp. · Feb 2002